Clinical and Industry News January 2008

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Abiomed Receives FDA Approval for the Combination iPulse^™ Circulatory Support System

Abiomed, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for U.S. commercial distribution of the company’s combination iPulse^™ Circulatory Support System. The iPulse drives Abiomed and other manufacturer’s intra-aortic balloons (IAB), Abiomed’s BVS^® 5000 and AB5000^® Ventricular Assist Devices (VAD), as well as new products Abiomed may offer in the future. These products are designed to treat patients suffering from acute heart failure by offering various levels of cardiac support, whether minimal, moderate, or full bi-ventricular, to potentially recover the patient’s native heart. The iPulse is the first console with the capability to provide either VAD or IAB support in the catheterization lab and surgery suite.
There are an estimated 160,000 IABs used globally each year with approximately 110,000 annual U.S. procedures. Over 1,000 open heart hospitals, which include approximately 100 transplant hospitals, could potentially use an IAB today as their initial level of circulatory support in the U.S. Based on Abiomed’s internal testing during 510(k) clearance of its IAB, the company believes its IAB has the fastest inflate-deflate time, and best performance relative to abrasion resistance and triggering. The iPulse should be a more cost-effective system for heart hospitals by supporting procedures with associated Medicare reimbursement that extends across four diagnostic-related groups (DRGs) ranging from approximately $20,000 to $215,000 per patient stay.
The current installed base of Abiomed’s AB5000 Circulatory Support System, prior to the approval of the iPulse, is comprised of approximately 50% of the U.S. transplant hospitals and approximately 20% of the U.S. open heart hospitals. Abiomed’s iPulse is also approved in Europe under CE-mark. For additional information please visit www.abiomed.com [5].

Scholarship Fund Established for RPA/RAs at Weber State University

As of January 2008, several anonymous donors have established the Dr. Harvey Aaron Koolpe Award of Excellence for Radiology Practitioner Assistants (RPAs) through the Dumke College of Health Professions Radiologic Sciences Department, Weber State University, Ogden, Utah. The first award will be presented in 2009 to a graduating RPA student, who achieves at least a GPA of 3.7; is a team leader in his (her) class; writes and has published his (her) required thesis in medical journal or magazine; and receives three outstanding evaluations from three sponsoring physicians, who functioned as clinical advisors during the student’s two-year residency.
This scholarship award has been set up through benefactors to recognize Dr. Koolpe, who passed away on October 18, 2007 from major complications following extensive lower back surgery. This physician was a terrific educator, medical device inventor, and an accomplished cardiovascular medical imaging physician. He completed his radiology residency under the tutelage of Dr. Constantin “Stan” Cope in Philadelphia, Pennsylvania. Then this late pioneer finished his cardiovascular medical imaging fellowship under the directorships of Dr. Manuel Viamonte, Jr. and Dr. James R. LePage in Miami, Florida. His involvement with the RPAs began in 2005, when he was invited to speak at the Sixth Annual National Society of Radiology Practitioner Assistants (NSRPA) in Las Vegas, Nevada. From this experience, he became more involved with the movement as an annual lecturer. He also was as an advocate, helping RPAs to be recognized and accepted by the practicing radiologists and other physicians performing medical imaging procedures in medical facilities that lacked adequate physician and advanced level medical imaging physician extenders. A panel which abides to the policies and procedures set forth by the university for such establishments has been formed. Friends and peers who have an interest in the scholarship may contact Ms. Rebecca Ory Hernandez, Weber State University Alumni Office, Weber State University, 3850 University Circle, Ogden, Utah 84408. If more information is needed, she can be contacted by phone at (801) 626-6566 or by e-mail at rohernandez@weber.edu [6].

One-Year ACUITY Trial Results: Bivalirudin therapy alone resulted in similar long-term ischemic outcomes compared to heparin plus GP IIb/IIIa combination
The Journal of the American Medical Association (JAMA) published one-year results of the ACUITY trial, which show that acute coronary syndrome (ACS) patients treated with bivalirudin (Angiomax®) alone had similar rates of ischemic clinical outcomes compared with a more complicated treatment regimen of heparin plus a glycoprotein IIb/IIIa inhibitor (GP IIb/IIIa).1 These findings confirm previously published ACUITY 30-day results, which showed similar ischemia at 30 days and nearly 50% fewer episodes of major bleeding. ACUITY principal investigator Gregg W. Stone, MD, Chairman of the Cardiovascular Research Foundation and Professor of Medicine, Columbia University Medical Center said, “Long-term findings from ACUITY confirm the durable efficacy of bivalirudin supporting a simpler, more cost-effective option than the heparin plus GP IIb/IIIa combination.”
John Kelley, President and Chief Operating Officer of The Medicines Company, which markets Angiomax, said “ACUITY also adds important new information on the value of starting Angiomax treatment earlier, in the emergency department, before the patient enters the cath lab.”
Based on results of the ACUITY trial, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) recently recommended extending the indication for bivalirudin (Angiox^®, the trade name for bivalirudin in Europe) to adult patients with ACS planned for urgent or early intervention. Bivalirudin should be administered with aspirin and clopidogrel. In the United States, The Medicines Company expects the Food and Drug Administration (FDA) to act in the second quarter of 2008 on an application to expand the use of Angiomax to include the emergency use of the drug in ACS patients.
ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) was one of the largest ACS clinical trials ever conducted to evaluate anti-thrombotic therapies and enrolled 13,819 high-risk patients in 450 centers worldwide. The open label trial design employed an early invasive strategy (angiography within 72 hours), starting anti-clotting therapy when ACS patients arrived at the emergency department and randomly assigning them to treatment with standard of heparin (unfractionated or enoxaparin) plus GP IIb/IIIa, bivalirudin plus GP IIb/IIIa, or bivalirudin monotherapy. In the bivalirudin monotherapy group, selective use of GP IIb/IIIa was permitted in limited circumstances and occurred in less than 10% of patients. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management (e.g., various anti-clotting drugs), bypass surgery or percutaneous coronary intervention (PCI).
The one-year ACUITY analysis showed that, in patients undergoing treatment in the bivalirudin alone group, the bivalirudin plus GP IIb/IIIa group and the heparin plus GP IIb/IIIa group, respectively:
Death occurred in 3.8%, 3.9% and 3.9% of patients (differences not significant). Composite ischemia events occurred in 16.2%, 16.0% and 15.4% of patients (differences not significant).
Composite ischemia was defined as death, heart attack or unplanned revascularization for ischemia.
Previously reported findings from ACUITY showed that bivalirudin was associated with significantly less bleeding at 30 days than heparin plus GP IIb/IIIa: 3.0% vs. 5.7% (p < 0.001).² The one-year results from ACUITY were initially presented at the American College of Cardiology annual meeting in March 2007.²
The American Heart Association and the American College of Cardiology recommend that moderate- and high-risk ACS patients undergo angiography and, based on the results, be treated through medical management, bypass surgery, or PCI. Heparin plus GP IIb/IIIa is often used as part of these treatments to reduce the risk of blood clotting and further ischemia. However, while heparin plus GP IIb/IIIa can reduce the risk of ischemia, heart attack and death in ACS patients, it also increases the risk of major bleeding, which ACUITY showed, increases the risk of death.

References
1. Stone GW, Ware JH, Bertrand ME, et al. Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management: One-year results from the ACUITY trial. JAMA 2007 Dec 5; 298(21): 2497–2506.
2. Stone GW, Bertrand ME, Lincoff AM, et al. A prospective, randomized trial of bivalirudin in acute coronary syndromes: one year results from the ACUITY trial. Presented at: 56th Annual Scientific Session of the American College of Cardiology, New Orleans, March 24-27, 2007.

BioImage Study Seeks to Identify Individuals at High Risk of Heart Attack or Stroke 2-3 Years before Occurrence
Next phase of the High-Risk Plaque Initiative will leverage advances in diagnostic imaging and blood biomarker science to reduce morbidity, mortality and cost associated with cardiovascular disease
BG Medicine, on behalf of the High-Risk Plaque Initiative, announced the launch of the BioImage Study, designed to discover new blood tests and to optimize non-invasive imaging of atherosclerosis in order to identify and characterize individuals that are at high-risk for coronary heart disease or stroke. The BioImage Study is the next phase of the High-Risk Plaque Initiative, an industry-funded joint research and development effort to advance the understanding, recognition and management of high-risk plaque (HRP), the primary underlying cause of heart attacks and the leading cause of death in the Western world.
The current method of reducing cardiovascular disease relies on minimizing risk factors, an effective strategy to some degree, but insufficient for treating established but asymptomatic disease such as HRP. Although the pharmaceutical industry has discovered promising treatment options to reduce the risk of heart attack or stroke associated with HRP, the therapeutic potential of these drugs is compromised by a general inability to identify the people who would benefit most from them. The BioImage Study is designed to identify those individuals with undetected but high-risk atherosclerosis in the months or years before a heart attack or stroke occurs, by taking advantage of the latest technologies in biomedical imaging and molecular medicine. This approach integrates a set of clinical measurements that may reliably and reproducibly predict those who are most at risk of heart attack or stroke associated with HRP and would benefit from innovative therapies.
“The BioImage Study is expected to answer many important questions that would help us devise strategies to markedly reduce the burden of cardiovascular disease,” said Valentin Fuster, MD, PhD, a leading international cardiologis, chairman of the Scientific Advisory Board for the HRP Initiative and principal investigator of the BioImage Study. “The collaboration between academia, diagnostic and therapeutic industry participants and a leading health benefit provider creates an unprecedented opportunity to do a different kind of study to search for these answers in a way that would otherwise not be possible.” In addition to his work with the HRP Initiative, Dr. Fuster serves as director of the Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health and Director of Mount Sinai Heart.
Participants in the BioImage Study will have physical measurements taken (e.g., height, weight, blood pressure and waist/hip circumferences) and blood samples drawn for a number of advanced molecular analyses. Many of these participants will also undergo procedures to capture images of their hearts and cardiovascular systems. Based on this information, the HRP Initiative will work to discover and validate blood biomarkers that correlate with the imaging data, and that are predictive of future heart attack and stroke associated with HRP.
The BioImage Study is novel not only in its design, but also in the collection of collaborative partners who have joined the HRP Initiative to address this critical medical need. Together with BG Medicine, these partners include Merck, AstraZeneca, Philips, and several distinguished members of academia. The current group of HRP Partners is seeking additional companies to collaborate in the HRP Initiative.
Humana, one of the largest publicly traded health benefits companies in the U.S., will offer to selected members in Illinois, Kentucky and Southern Florida the opportunity to participate in the BioImage Study. The study uses mobile diagnostic imaging units equipped with Philips magnetic resonance (MR) and computed tomography (CT) systems. These units will be located at the sites in Illinois, Kentucky and Florida and will seek to enroll a total of 7,300 volunteers. The BioImage Study, which began in December 2008 in Chicago, is expected to end in December 2008 in Florida and will enroll males age 55-80 and females age 60-80.
The HRP Initiative aims to collaborate on the discovery and development of improved techniques for identifying individuals at risk for heart attacks and the advancement of methods to monitor disease progression and response to treatment. The Initiative expects to provide a total of $30 million in funding over four years and will leverage recent advances in biology and technology to design and optimize a patient care-cycle for high-risk plaque. Currently, Merck, AstraZeneca, and Philips have joined biotechnology research company BG Medicine in this important initiative, which aims to reduce morbidity, mortality and costs associated with cardiovascular disease.

Yale Launches Study of Young Women with AMI
The largest, most comprehensive study of young women with heart attacks — VIRGO (Variation in Recovery: Role of Gender on Outcomes in Young AMI patients) — was recently launched at Yale School of Medicine with a $9.7 million National Institutes of Health grant.
“This is the first study to focus on this high risk-and highly unstudied-group,” said Yale School of Public Health Associate Professor Judith Lichtman, co-principal investigator of the study. “There have been no large, prospective studies of this population, even though the death toll is comparable to that from breast cancer.”
She said the research team is exploring what accounts for premature heart disease in women and why they experience worse outcomes than men of similar age with heart disease.
The four-year grant will support the study of 2,000 women age 55 and younger with 1,000 men for comparison. The multi-site study bridges disciplines from basic biology and clinical sciences to psychology and health services research.
Although women under age 55 with heart attacks represent a small proportion of all patients with heart disease, they account for about 40,000 hospitalizations each year. About 8,000 women under the age of 55 die of heart disease annually, ranking it among the major causes of death in this group. While most women in this age group are protected from heart disease, notes Lichtman, prior research indicates that young women have a much greater risk of dying after a heart attack than men of the same age.
The study addresses questions ranging from genetics and clinical care to outcomes, including: How are outcomes of women different from those of men? What are the genetic, demographic, psychosocial, and behavioral factors that contribute to premature heart disease in women? How do delays in clinical presentation and treatment affect the risk and outcomes of women? Do women get the same quality of care as men?
“Despite the increasing focus on women with heart disease in recent years, we know little about heart disease in this population,” said principal investigator Harlan M. Krumholz, MD, the Harold H. Hines, Jr. Professor of Medicine and Epidemiology and Public Health at Yale School of Medicine. “Since young women with heart disease are relatively rare at any one hospital, we have assembled an unprecedented network of almost 100 sites nationwide to identify and enroll women for this ground-breaking study.”
The investigators have also developed a novel partnership with the American Heart Association’s Go Red For Women, a national movement to raise awareness of heart disease and to empower women to reduce their risk by learning about prevention. The investigators will also collaborate with various other organizations.

MIT Works Toward Engineered Blood Vessels
Tissue could be used in human body Massachusetts Institute of Technology (MIT) scientists have found a way to induce cells to form parallel tube-like structures that could one day serve as tiny engineered blood vessels. The researchers found that they can control the cells’ development by growing them on a surface with nano-scale patterning. A paper on the work was posted this month in an online issue of Advanced Materials.
Engineered blood vessels could one day be transplanted into tissues such as the kidneys, liver, heart or any other organs that require large amounts of vascular tissue, which moves nutrients, gases and waste to and from cells.
“We are very excited about this work,” said Robert Langer, MIT Institute Professor and an author of the paper. “It provides a new way to create nano-based systems with what we hope will provide a novel way to someday engineer tissues in the human body.”
The work focuses on vascular tissue, which includes capillaries, the tiniest blood vessels, and is an important part of the circulatory system. The team has created a surface that can serve as a template to grow capillary tubes aligned in a specific direction. The researchers built their template using microfabrication machinery at Draper Laboratory in Cambridge. Normally such technology is used to build micro-scale devices, but the researchers adapted it to create nano-scale patterns on a silicone elastomer substrate. The surface is patterned with ridges and grooves that guide the cells’ growth.
The cells can sense (the patterns), and they end up elongated in the direction of those grooves,” said Christopher Bettinger, MIT graduate student in materials science and engineering and lead author of the paper. The cells, known as endothelial progenitor cells (EPCs), not only elongate in the direction of the grooves, but also align themselves along the grooves. That results in a multicellular structure with defined edges, also called a band structure.
Once the band structures form, the researchers apply a commonly used gel that induces cells to form three-dimensional tubes. Unlike cells grown on a flat surface, which form a network of capillary tubes extending in random directions, cells grown on the nano-patterned surface form capillaries aligned in the direction chosen by the researchers.
The researchers believe the technique works best with EPCs because they are relatively immature cells. Earlier attempts with other types of cells, including mature epithelial cells, did not produce band structures.
Growing tissue on a patterned surface allows researchers a much greater degree of control over the results than the classic tissue engineering technique of mixing cell types with different growth factors and hoping that a useful type of tissue is produced, said Bettinger. “With this technique, we can take the guesswork out of it,” he said. The next step is to implant capillary tubes grown in the lab into tissues of living animals and try to integrate them into the tissues.

Top Research Advances Include Studies on Genetics and Stem Cell Research, Stents American Heart Association 2007 year-end report
Several new studies on genetics and stem cell research, along with studies that continue to debate the use of stents to clear coronary artery blockages, are among the top research advances in heart disease and stroke for 2007, said Daniel W. Jones, MD, president of the American Heart Association.
Other major milestones include a study that may change how lives are saved using a new method of cardiopulmonary resuscitation.
The American Heart Association in 1996 began compiling an annual list of the top 10 major advances in heart disease and stroke research and continues to highlight influential research annually.
Achievements in 2007 include:

1. Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls Genome-wide association studies identify genes (strands of DNA) that may cause specific diseases and represent a powerful approach in identifying genes involved in common human diseases. This large-scale genome-wide association (GWA) study found consistent and replicable genetic markers of several complex diseases of adulthood, including atherosclerotic heart disease. Study authors said their analysis of some 17,000 people for seven common familial diseases (bipolar disorder, coronary artery disease, Crohn’s disease, hypertension, rheumatoid arthritis, type 1 diabetes and type 2 diabetes) confirms previously identified loci (DNA closely linked to genes that may identify a trait of a particular disease) and provides strong evidence for many novel disease susceptibility genes.
Source: Nature, June 7, 2007; Nature 2007. 447:661-78;www.nature.com [7].
Funding: Wellcome Trust was the principle funding source of this study.

2. Genome-wide association analysis of coronary artery disease This study included a joint analysis of two genome-wide association studies of coronary artery disease. Researchers used the genetic patterns of the persons (cases) with coronary artery disease (CAD) from the Wellcome Trust Case Control Consortium study (described above) and tried to replicate the genetic patterning for CAD in another genome-wide association study — the German MI [Myocardial Infarction] Family Study. Results identified several genetic loci that, individually and in aggregate, substantially affect the risk of developing coronary artery disease. Source: New England Journal of Medicine, Aug. 2, 2007; N Engl J Med 2007;357:443-453; www.nejm.org [8].
Funding: Grants from the Wellcome Trust, the National Genome Research Network 2 of the German Federal Ministry of Education and Research and the Cardiogenics project of the European Union supported this study.

3. Cardiopulmonary resuscitation by bystanders with chest compression only (SOS-Kanto): An observational study This work represents the first meaningful chance to improve cardiopulmonary resuscitation (CPR) in more than 50 years. Results indicate chest compression-only resuscitation by bystanders may be the preferable approach to resuscitation for adult patients with witnessed out-of-hospital cardiac arrest, especially those with apnea, shockable rhythm or short periods of untreated arrest. Source: The Lancet, March 17, 2007. The Lancet 2007; 369:920-926; www.thelancet.com [9].
Funding: Grants from the Laerdal Foundation of Acute Medicine, Norway and the Ministry for Health, Labour and Welfare, Japan, supported this study.

4. Implementation of a statewide system for coronary reperfusion This study found that a statewide program focused on regional systems for quickly treating ST-elevation myocardial infarctions (STEMI) can significantly improve quality of care. The research sets the stage for collaborative, non-competitive care for patients of a region, expanding door-to-balloon initiatives into the community for a systems approach. The American Heart Association’s Mission: Lifeline program, created to establish systems to provide emergency care for STEMI patients, promotes this strategy for improving patient care. Source: Journal of the American Medical Association, Nov. 28, 2007; JAMA 2007; 298(20);2371-23809; www.jama.org [10]. This study was also presented at the American Heart Association Scientific Sessions 2007.
Funding: Blue Cross and Blue Shield of North Carolina supported this study.

5. Long-term effects of dietary sodium reduction on cardiovascular disease outcomes: observational follow-up of the trials of hypertension prevention (TOHP) This is the first major trial to document that a reduced sodium intake lowers the risk of clinical cardiovascular disease outcomes, not just blood pressure. Source: British Medical Journal, April 20, 2007; BMJ 2007;334;885; www.bjm.com [11].
Funding: The National Heart, Lung and Blood Institute, National Institutes of Health supported this study.

6. Optimal medical therapy with or without PCI for stable coronary artery disease (COURAGE) This study compared the initial management strategy of percutaneous coronary intervention (PCI) with intensive pharmacologic therapy and lifestyle intervention (optimal medical therapy) vs. optimal medical therapy alone in reducing the risk of cardiovascular events. The authors concluded that, as an initial management strategy in patients with stable coronary artery disease, PCI did not reduce the risk of death, myocardial infarction or other major cardiovascular events when added to optimal medical therapy. Source: New England Journal of Medicine, April 12, 2007; N Engl J Med 2007; 35;(15);1503-16; www.nejm.org [8].
Funding: The U.S. Department of Veterans Affairs Office of Research and Development provided support for this study.

7. The generation of functional cardiomyocytes from adult mouse spermatogonial stem cells This study analyzed the complex functional properties of cardiomyocytes (heart muscle cells) derived from maGSCs in vitro and the behavior of undifferentiated maGSCs in normal hearts of mice in vivo after transplantation. The authors conclude that maGSCs provide a new source of distinct types of cardiomyocytes for basic research/potential therapeutic application. Source: Circulation Research, June 8, 2007; Circ Res 07 Jun 8;100(11):1615-25; www.ahajournals.org [12].
Funding: A grant from the Georg-August-University of Gottingen supported this study.

8. HORIZONS: Harmonizing Outcomes with RevascularIZatiON and Stents This large study examined the safety and effectiveness of anticoagulation medications and drug-eluting stents in patients experiencing a STEMI, without significantly increasing the rate of death or recurrent heart attacks among these patients. Source: Late-breaking trial at the Transcatheter Cardiovascular Therapeutics TCT 2007; www.tct2007.com [13].
Funding: The Cardiovascular Research Foundation supported this study.

9. Effectiveness and safety of drug-eluting stents in Ontario This large Canadian study found that drug-eluting stents are effective in reducing the need for target-vessel coronary artery bypass in patients at the highest risk for re-narrowing of previously blocked arteries, without a significantly increased rate of death or heart attack. Source: New England Journal of Medicine, Oct. 7, 2007; N Engl J Med 2007; 14;357:1393–1402; www.nejm.org [8].
Funding: The Ontario Ministry of Health and Long-Term Care to the Program for Assessment of Technology in Health, the CCN of Ontario and the Institute for Clinical Evaluative Sciences supported this study in part.

10. Underdiagnosis of hypertension in children and adolescents This study of more than 14,000 children found that hypertension and prehypertension were often undiagnosed in the pediatric population. Patient age, height, obesity-related diagnoses, and magnitude and frequency of abnormal blood pressure readings all increased the odds of hypertension. Source: Journal of the American Medical Association, Aug 2007; JAMA 2007; 298(8):874–879; www.jama.org [10].
Funding: This research did not receive funding support.

Statements and conclusions of study authors are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.

Heart Attack Risk From Smoking Due to Genetics
Heart attacks among cigarette smokers may have less to do with tobacco than genetics. A common defect in a gene controlling cholesterol metabolism boosts smokers’ risk of an early heart attack, according to a study in Annals of Noninvasive Electrocardiology. The findings also show that smokers without the defect normally have heart attacks no sooner than their non-smoking peers.
Although the link between smoking and heart disease was established decades ago, the reasons for that link were unclear. More recent studies suggest smoking interferes with cholesterol metabolism, lowering smokers’ levels of high-density lipoprotein, the good cholesterol that protects against heart-attack risk. An estimated 55 to 60 percent of smokers face the added risk of a defective gene that also lowers levels of the protective high-density lipoprotein. Therefore, the combination of smoking plus a defective gene substantially accentuates the risk of heart attacks in these patients.
Researcher Ilan Goldenberg, MD, and colleagues were the first to evaluate both smoking history and the genetic trait in heart-attack patients. They found that smokers with the genetic defect had their first heart attack eight to nine years earlier than non-smokers. Smokers with a healthy version of the gene had their first heart attack only three years earlier than non-smokers, a difference the researchers considered non-significant.
“Since the frequency of this ‘bad’ gene in the general population is about 60 percent, many people who smoke have a high risk of experiencing a heart attack at a young age,” Goldenberg said. “This finding should increase awareness for smoking cessation.”

Cardiovascular Disease Death Rates Decline, but Risk Factors Still Exact Heavy Toll American Heart Association Statistical Update
Cardiovascular disease (CVD) death rates are declining, but CVD is still the No. 1 cause of death in the United States, and risk factor control remains a challenge for many, according to the most recent data from the American Heart Association’s Heart Disease and Stroke Statistics — 2008 Update. The Update is available in the Dec. 17 online issue of Circulation: Journal of the American Heart Association at http://www.americanheart.org/statistics [14].
The Update provides statistics about cardiovascular diseases, risk factors, treatments, quality of care and costs. The American Heart Association does not generate the data, but synthesizes it from many sources and provides it online without charge for government policymakers, physicians, researchers, educators and the public, making the Update a unique national — and even international — resource.
Cardiovascular diseases include heart disease, stroke, high blood pressure, heart failure and several other conditions including arrhythmias, atrial fibrillation, cardiomyopathy and peripheral arterial disease. CVD has been the leading cause of death in the United States every year since 1900 except during the 1918 flu epidemic. In 2004, the most recent year for which final statistics were available for this report, the age-adjusted CVD death rate per 100,000 persons was 288.0, compared to 307.7 in 2003. CVD (the No. 1 overall cause of death) was listed as the underlying cause of death in 869,724 deaths, compared to 911,163 deaths in 2003. Cancer was the second-leading cause of death, responsible for 553,888 lives lost. Stroke, when considered separately from other cardiovascular diseases, was the nation’s third-leading killer (150,074 deaths), followed by accidents (112,012). Coronary heart disease, even when considered separately from other cardiovascular diseases, was still by far the nation’s single leading cause of death (451,326).
“These statistics make it clear that cardiovascular disease remains, by far, our greatest public health challenge,” said Donald Lloyd-Jones, MD, ScM, chair of the association’s Statistics Committee, which, along with the association’s Stroke Statistics Subcomittee, is responsible for the Update.
While CVD deaths appear to be decreasing, the prevalence of many related risk factors is holding steady or increasing. Overweight, in both adults and children, has been rising for several decades. Sixty-six percent of adults are overweight while 31.4 percent are obese. Seventeen percent of children and adolescents ages 12–19 are overweight, along with 17.5 percent of children ages 6–11, and 14 percent of children ages 2–5.
“Although we have made some substantial strides in understanding the causes of cardiovascular disease, the data in this publication show that we have a long way to go to capture people’s attention and to implement the prevention and treatment programs we need,” said Lloyd-Jones, an associate professor in the Department of Preventive Medicine at Northwestern University’s Feinberg School of Medicine in Chicago.
Changing dietary habits appear to be fueling increased obesity, because many Americans are not consuming recommended levels of foods like fruits and vegetables. As cited in the Update, data from the Youth Risk Behavior Surveillance Study of the Centers for Disease Control and Prevention (CDC) shows that in 2005, among high school students, only 21.4 percent of males and 18.7 percent of females reported eating at least five daily servings of fruits and vegetables. A 2005 Behavioral Risk Factor Surveillance Study (CDC) shows that fewer than one in three U.S. adults consumes fruit two or more times per day, and only 27.2 percent eat vegetables three or more times per day.
Smoking, which raises the risk of coronary heart disease death two to three times, remains highly prevalent. More than 46 million U.S. adults are daily smokers, and about 4,000 people ages 12–17 begin smoking every day.
The 2008 Update includes enhanced content for diabetes, a major cardiovascular risk factor, and end-stage renal disease and chronic kidney disease, commonly associated with diabetes and high blood pressure. Based on 1984–2004 National Health and Nutrition Examination Studies, it is projected that diabetes prevalence will more than double from 2005 to 2050. About a third of the more than 15.1 million people with diabetes don’t know they have it, and another 59.7 million have prediabetes (a fasting blood glucose level between 100 and 125 milligrams per deciliter), which greatly increases the risk of diabetes. The Update cites a 2007 report in Circulation: Journal of the American Heart Association, which suggests that the increasing prevalence of diabetes is leading to an increasing prevalence of CVD morbidity and mortality. (At least 65 percent of people with diabetes die from some type of cardiovascular disease.)
Kidney disease is also on the rise. A projection by the U.S. Renal Data System says the number of people requiring treatment for kidney failure could increase 60 percent between 2001 and 2010.
The Update includes continued good news on improvements in the quality of care CVD patients receive at the nation’s hospitals. According to the ADHERE study, among 159,168 patients treated for heart failure at 285 U.S. hospitals in 2002–04, there were improvements in clinical outcomes and in the number of patients receiving counseling at discharge, smoking cessation counseling, prescription of beta blockers, and assessment of left ventricular function.
The American Heart Association also reports continued improvements in quality of care, through its Get With The Guidelinessm (GWTG) program, which works with participating hospitals to increase adherence to treatment guidelines for patients with coronary artery disease (CAD), stroke and heart failure:
• Using data from 58,847 patients who were admitted to 315 participating hospitals in 2006, the GWTG–CAD program reports the composite quality of care based on several performance measures was 89 percent, up from 86.3 percent in 2005. Performance measures include whether patients received aspirin, cholesterol-lowering drugs and other medications when they were discharged from the hospital and whether they were counseled to quit smoking.
• From 2006 data of 141,449 patients at 778 hospitals, the GWTG–Stroke program reports a composite quality of care score of 90 percent, up from 88 percent in 2005. Key performance measures for stroke include the administration of clot-busting therapy in eligible patients, proper anti-clotting medications during the hospital stay and, upon discharge, cholesterol-lowering therapy and counsel to quit smoking.
• GWTG–Heart Failure reports a composite quality of care score of 88 percent based on data from 35,576 patients in 231 hospitals in 2006, up from a 2005 composite score of 82.5. Performance measures include giving patients a complete set of discharge instructions, measuring left-ventricular function, counsel to quit smoking, and release from the hospital with proper medications.

While the quality of hospital care for patients with cardiovascular disease appears to be improving, the cost associated with cardiovascular disease will rise to a projected $448.5 billion in 2008, an increase of more than $16 billion over projections for 2007.

Vascular Solutions Launches Pronto® LP Extraction Catheter
Vascular Solutions, Inc. recently launched the Pronto^® LP (low profile) extraction catheter. The Pronto LP catheter is designed for soft thrombus aspiration from coronary and peripheral arteries as small as 1.5mm in diameter. The rapid exchange Pronto LP catheter is compatible with any 0.014” guidewire and is designed specifically for aspirating soft thrombus from smaller distal vessels. It combines a low crossing profile with a hydrophilic coating and a braid- and stylet-reinforced proximal shaft. The preloaded stylet provides kink-resistant delivery that can be removed rapidly to allow for full-lumen aspiration. Compatible with all 6F guide catheters (min I.D. 0.066”), the catheter is packaged with all components necessary for soft thrombus removal. The Pronto LP is currently available in the United States, along with additional Pronto catheters: the Pronto V3 catheter, the larger Pronto .035 catheter and the specialty Pronto-Short catheter.

U.S. Physician Wants All Non-heart Drugs Tested for Cardiovascular Risk
A U.S. physician-scientist insists that current regulatory policies should be strengthened to ensure acceptable cardiovascular safety of medicines primarily developed for non-cardiovascular medical problems. Dr. Jeffrey Borer, an authority in cardiovascular medicine and surgery at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, recommends earlier testing of all drugs’ cardiovascular effects. He also stresses the importance of authorising regulatory bodies to mandate continuing evaluation of drug effects, even after approval for marketing.
“The importance of evaluating the cardiovascular safety of new drugs has been highlighted by recent examples of drugs — anti-arthritis drugs and others — that were withdrawn from the market when unacceptable cardiovascular risks were discovered after regulatory approval,” says Dr. Borer.
Even though a medicine has been developed to cure some other condition, he says, its possible effects on cardiac physiology/pharmacology should be tested in animal studies. Dr. Borer stresses that similar evaluations should begin in the earliest phases of drug testing in patients.
He says that the definitions of adverse cardiovascular events like heart attacks and strokes should be standardized for all observers before the drug is administered to any patient. Currently, the definition of adverse events is left up to each observer individually, limiting the strength of conclusions about cardiovascular safety.
Dr. Borer also suggests that regulatory bodies be given more teeth so that they can withdraw approval of medicines if mandated post-marketing studies have not been performed. He made these suggestions at the recent annual meeting of the European Society of Cardiology in Vienna. A report on his recommendations has been published in the European Heart Journal.